MATERIAL SAFETY DATA SHEET
M anufacturer's Name: ALTANA INC.
Divisions: E. FOUGERA & CO. DIVISION
PHARM ADERM DIVISION
Street Address: 60 BAYLIS ROAD
City, State, Zip Code: M ELVILLE, NEW YORK 11747
(800) 424-9300, (631) 454-7677
Emergency Telephone No.:
SECTION 1: IDENTITY
Product Name: Nystatin Cream USP
Synonyms: Nystex
CAS #: Not applicable.
Chemical Family: Antifungal antibiotic.
Formula: Nystatin, Polysorbate 60, Aluminum Hydroxide Compressed Gel, Titanium Dioxide, Glyceryl Monostearate,
Polyethylene Glycol 400 Monostearate, Simethicone, Sorbic Acid, Propylene Glycol, Ethylenediamine,
Polyoxyethylene Fatty Alcohol Ether, Sorbitol Solution, Methylparaben, Propylparaben, Hydrochloric Acid, White
Petrolatum, Purified Water.
SECTION 2: SAFETY and HAZARD RATINGS
RATINGS
Health (Acute-Chronic): 1鈥?1
Minimal 0
Flammability: 1
Slight 1
Reactivity: 0
Moderate 2
Environment (Air-W ater-Soil): 0鈥?0鈥?1
Severe 3
Special Hazards: Not indicated.
Extreme 4
Protective Equipment: General ventilation, eye and hand wash.
SECTION 3: EM ERGENCY and FIRST AID PROCEDURES
Eyes: Flush eyes with plenty of water for at least 15 minutes.
Skin: W ash thoroughly with soap and water.
Ingestion: Give two glasses of water and induce vomiting if directed by medical personnel. Never give anything by mouth
to an unconscious person.
Inhalation: Remove to fresh air. If breathing is difficult, give oxygen. If breathing has stopped, give artificial respiration.
CALL A PHYSICIAN
CONTACT A POISON CONTROL CENTER
M SDS# 06A Nystatin Cream USP (M arch 31, 2006) Page 1 of 4
SECTION 4: INGREDIENTS
C A R C IN O G E N H A ZA R D D A T A
A C G IH O SH A
NAM E C A S# % IA R C NTP O SH A TLV PEL
Nystatin 1400-61-9 no no no not established
10mg/m3* not established
Polysorbate 60 9005-67-8 no no no
Aluminum Hydroxide 21645-51-2 no no no not established
10mg/m3 15mg/m3
Titanium Dioxide 13463-67-7 no no no
3
Glyceryl Monostearate 123-94-4 no no no 10mg/m * not established
10mg/m3* not established
Polyethylene Glycol 400 Monostearate 9004-99-3 no no no
Simethicone 8050-81-5 no no no not established
Sorbic Acid 110-44-1 no no no not established
Propylene Glycol 57-55-6 no no no not established
25mg/m3 25mg/m3
Ethylenediamine 107-15-3 no no no
Polyoxyethylene Fatty Alcohol Ether n/a no no no not established
Sorbitol 50-70-4 no no no not established
Methylparaben 99-76-3 no no no not established
Propylparaben 94-13-3 no no no not established
7mg/m3** not established
Hydrochloric Acid 7647-01-0 no no no
White Petrolatum 8009-03-8 no no no not established
Water 7732-18-5 no no no not established
*Stearates **Ceiling
SECTION 5: FIRE and EXPLOSION HAZARD DATA
Flash Point: Not determined.
Auto-ignition Temperature NF: Not determined.
Flammable Limits in Air by Volume LEL: Not determined.
UEL: Not determined.
Extinguishing M edia: Alcohol foam, Dry chemical, Carbon dioxide.
Special Fire Fighting Procedures: W ear full protective clothing and self-contained breathing apparatus.
Unusual Fire and Explosion Hazards: M ay emit toxic fumes when burning.
SECTION 6: REACTIVITY DATA (PHYSICAL HAZARDS)
Stability: [ X ] Stable [ ] Unstable
Conditions and Chemicals to Avoid: Avoid extreme heat, sparks, open flame and oxidizers.
Hazardous Combustion or Carbon dioxide, Carbon monoxide.
Decomposition Products:
Hazardous Polymerization: [ ] M ay Occur [ X ] W ill Not Occur
M SDS# 06A Nystatin Cream USP (M arch 31, 2006) Page 2 of 4
SECTION 7: HEALTH HAZARDS
Primary Route(s) of Entry: Dermal, Ingestion.
Signs and Symptoms of Exposure
a. Overexposure Effects: a. M ay cause nausea, vomiting and diarrhea.
b. Chronic Effects:
1. Inhalation: 1. Not likely due to the physical state of the product.
2. Eyes: 2. Not for ophthalmic use. M ay cause irritation.
3. Skin: 3. Not toxic under standard application. If irritation should occur, discontinue use.
4. Ingestion: 4. M ay cause nausea, stomach pain, vomiting and diarrhea.
5. M edical Conditions 5. M ay cause allergic reactions in susceptible individuals. Carcinogenicity studies on
Potentially Aggravated: polyethylene (19,157,79) have been reviewed by IARC who found that they 鈥渄o not
permit an evaluation of its carcinogenicity.鈥?
SECTION 8: SPECIAL PRECAUTIONS and SPILL/LEAK PROCEDURES
Precautions to be Taken in Keep container tightly closed at all times when not in use. Store at controlled room
Handling/Storage: temperature 15N鈥?30NC (59N鈥?86NF). Avoid extreme heat, sparks, open flame and
oxidizers.
Hygienic Practices: W ash thoroughly after handling. Use normal hygiene to protect hands, eyes and skin.
Use general ventilation to protect your lungs. Do not wear contaminated clothing
until thoroughly laundered.
W hen M aterial is Released or Spilled: Assure slippery conditions are nullified. Add sand or dirt. Scoop up and remove.
W ash area with soap and water. Dispose of in accordance with federal, state and local
regulations.
W aste Disposal M ethods: Assure conformity with applicable disposal regulations. Dispose of absorbed material
at approved incineration or chemical landfill waste disposal site.
SECTION 9: SPECIAL PROTECTION INFORM ATION
Respiratory Protection: General ventilation.
Skin Protection: Normal hygiene.
Eye Protection: Normal hygiene.
Other Protective Clothing or Equipment: As needed to prevent repeated/prolonged contact.
SECTION 10: CONTAINERS and LABELING
Special Precautions: Keep container tightly closed at all times when not in use. Store at
controlled room temperature 15N鈥?30NC (59N鈥?86NF). Avoid extreme heat,
sparks, open flame and oxidizers. As supplied (not sold in bulk quantity).
Recommended Container: Avoid physical damage and heat.
Protect the Container by: Cool, dry conditions.
Container Should be Handled in an Area W ith: Not reusable.
The Empty Container is: Federal law prohibits dispensing without a prescription. For topical use
Precautionary Label: only. Not for ophthalmic use.
W arning Placard: Keep out of reach of children.
IM O Hazard Class #: Not applicable.
UN/NA #: Not applicable.
Hazard Classification: Not applicable.
DOT Name: Not applicable.
Shipping Instructions: Keep away from extreme heat, sparks, open flame and oxidizers.
M SDS# 06A Nystatin Cream USP (M arch 31, 2006) Page 3 of 4
SECTION 11: ENVIRONM ENTAL RISKS
Aquatic Toxicity: Not indicated.
Biodegradability: Not indicated.
Partition Coefficient: Not indicated.
SECTION 12: REGULATORY INFORM ATION
Refer to the following OSHA Regulations: If respirator used, 29 CFR 1910.134
references: DOT Regulations: Not applicable.
EPA Regulations: Not applicable.
Other: NDC: 0168-0054-15
0168-0054-30
SECTION 13: PHYSICAL DATA
Appearance and Color: A yellow-to-tan cream that is essentially odorless.
M olecular W eight: Not applicable.
pH: ~7
Refractive Index @ 20NC: Not applicable.
Viscosity CPS @ 25NC: Not determined.
Boiling Point: ~100NC (~212NF)
Freezing/M elting Point: Not determined.
Congealing Point: Not determined.
Vapor Pressure (mm Hg @ 20NC): Not determined.
Vapor Density (Air=1): Not determined.
Solubility in W ater: Disperses.
Solubility in Alcohol: Partly soluble.
Solubility in Oil: Partly soluble.
Specific Gravity (H 2O=1): 0.81
% Volatile by Volume: ~33 water
Evaporation Rate (Ether=1): 0.05
Date of Preparation/Change: Revision # 2 Replaces
M arch 31, 2006 M arch 31, 2003
The information presented herein relates to the specific material described and may not be valid for this material used in
combination with any other materials or in any process. This information is, to the best of our knowledge, accurate and reliable on
the date compiled. W e make no representation, warranty or guarantee as to its accuracy, reliability or completeness.
It is the reader's responsibility to ascertain whether the information supplied is suitable and complete for that person's specific
uses. This M aterial Safety Data Sheet was prepared for ALTANA INC. by:
COM PLIANCE INNOVATIONS, INC.
706 Route 15 South, Suite 207
Lake Hopatcong, New Jersey 07849
973-663-1120 鈥? fax 973-663-2378
helpdesk@chemply.com
M SDS# 06A Nystatin Cream USP (M arch 31, 2006) Page 4 of 4
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